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BIORA THERAPEUTICS, INC. (BIOR)·Q1 2024 Earnings Summary

Executive Summary

  • Q1 2024 focused on clinical execution and capital structure optimization rather than topline growth; operating expenses were $16.1M and net loss was $4.2M (EPS -$0.14), with modest revenue of $0.542M .
  • BT-600 (NaviCap + tofacitinib) advanced: dosing in the MAD cohort completed; single-dose results showed colon-targeted absorption with 3–4x lower plasma levels vs conventional oral tofacitinib; full SAD/MAD data expected late Q2 2024 .
  • BioJet platform exceeded its 15% bioavailability target in animals, recording advances in consistency and bioavailability with semaglutide and adalimumab; partnering process with pharma is underway with intent to confirm interest mid-2024 .
  • Financial catalysts: ~$31M raised over four months and further note exchanges reduced convertible balances; management is working to simplify the capital structure ahead of clinical readouts and potential partnerships .
  • Near-term stock reaction catalysts: late-Q2 topline BT-600 data, DDW presentation on NaviCap device function, and potential BioJet partnership updates .

What Went Well and What Went Wrong

What Went Well

  • BT-600 SAD results aligned with design goals: delayed systemic absorption consistent with colon delivery (6–8 hours), dose-proportional PK, and 3–4x lower plasma levels vs conventional oral dosing .
  • MAD cohort dosing completed (24 healthy participants; 5mg/10mg daily for 7 days) with tissue biopsies obtained; topline data expected late Q2 2024 .
  • BioJet preclinical progress surpassed target bioavailability (≥15%) with recent animal studies demonstrating improved consistency and bioavailability; active partnering process with encouraging interest from existing and new collaborators .

What Went Wrong

  • Limited revenue base continues (Q1 revenue $0.542M) and negative net income, reflecting pre-revenue development stage dynamics; EPS remained negative at -$0.14 in Q1 .
  • S&P Global consensus estimates for Q1 2024 EPS and revenue were unavailable for BIOR, limiting “beat/miss” benchmarking [GetEstimates error: BIOR mapping not available].
  • Capital structure remains complex with significant warrant and derivative liabilities, though management is actively simplifying through note exchanges and new capital raises .

Financial Results

MetricQ3 2023Q4 2023Q1 2024
Revenue ($USD Millions)$0.000 $0.000 $0.542
Net Loss ($USD Millions)$(73.454) $(15.413) $(4.189)
EPS ($USD)$(4.89) $(0.62) $(0.14)
Total Operating Expenses ($USD Millions)$23.321 $13.344 $16.058
Cash, Cash Equivalents and Restricted Cash ($USD Millions)$12.569 $15.211 $10.820
  • Versus prior year: Q1 2024 net loss improved to $(4.189)M vs $(17.441)M in Q1 2023; revenue $0.542M vs $0.002M in Q1 2023 .
  • Versus prior quarter: Q1 2024 net loss improved vs Q4 2023, while operating expenses rose vs Q4 (Q1: $16.058M, Q4: $13.344M) .
  • Versus estimates: S&P Global consensus EPS and revenue were unavailable for BIOR; thus, no beat/miss determination can be made for Q1 2024 [GetEstimates error: BIOR mapping not available].

Segment breakdown: Not applicable; BIOR does not report revenue by segment in these releases .

KPIs (Clinical and Platform Execution)

KPIPrior Quarter(s)Q1 2024Notes
BT-600 SAD completionSAD completed with colon-targeted absorption; 3–4x lower plasma vs conventional MAD dosing completed (24 participants; 5mg/10mg QD x7 days); tissue biopsies obtained Topline SAD/MAD data expected late Q2
NaviCap device functionFour human studies confirm targeted colon delivery DDW presentation on device function May 19 Full colonic coverage emphasized
BioJet bioavailabilityFirst-gen device exceeded 15% target; 20–40% in recent studies Further animal studies demonstrated advances in consistency and bioavailability; partnered molecules progressing Partner interest confirmation targeted mid-2024

Guidance Changes

Financial guidance: None provided for revenue, margins, OpEx, OI&E, tax rate, segments, or dividends in Q1 2024 releases/call .

Operational/milestone guidance:

MetricPeriodPrevious GuidanceCurrent GuidanceChange
BT-600 SAD/MAD topline dataLate Q2 2024Q2 2024 topline data (SAD/MAD) Late Q2 2024 topline data (SAD/MAD) Maintained
BT-600 UC patient study start2H 20242H 2024 initiation 2H 2024 initiation Maintained
NaviCap device function presentationMay 19, 2024 (DDW)DDW data presentation planned DDW presentation on device function confirmed Maintained
BioJet partnering process2024Aim for enhanced partnership in 2024 Running process; confirm partner interest by mid-2024 Clarified timeline

Earnings Call Themes & Trends

TopicPrevious Mentions (Q3 2023, Q4 2023)Current Period (Q1 2024)Trend
NaviCap/BT-600 PK and tissue targetingIND filed; plan for Phase 1; SAD results (6–8h delay, 3–4x lower plasma) MAD dosing completed; tissue biopsies; full data late Q2 Execution continuing; data readout imminent
BioJet oral delivery of large molecules≥15% target achieved; up to 30–40% bioavailability; collaborator studies Further animal data advances; active partnering process; mid-year interest confirmation goal Technical validation improving; BD momentum
Capital structure optimizationLarge debt reduction via note exchanges; new capital raised Further note exchange; $31M capital raised over four months; continued optimization planned Ongoing simplification; liquidity enhanced
Regulatory/legal cleanupIPO litigation settlement in principle; monetization of legacy asset Targeting reduction of legacy G&A spend by year-end Progress reducing legacy headwinds
R&D execution cadenceEmphasis on accelerated development timelines Maintaining accelerated cadence; DDW presentation; UC study in 2H Consistent acceleration

Management Commentary

  • “We observed a pharmacokinetic profile consistent with drug delivery and absorption in the colon... plasma levels of tofacitinib were approximately 3-4 times lower than conventional oral tofacitinib” — Adi Mohanty, CEO .
  • “Operating expenses during the first quarter… were $40.5 million, excluding stock-based compensation… Biora’s core OpEx spend was $11.5 million in Q1” — Eric d’Esparbes, CFO (call commentary clarifying cash burn) .
  • “The BioJet platform continues to exceed its performance targets… we believe we’re in an excellent position… running a partnering process… goal is to have partner stated interest confirmed by mid-year” — Aditya Mohanty .

Q&A Highlights

  • Physician perspective on BT-600’s 3–4x lower plasma levels: Management noted this reduction is slightly higher than expectations and coupled with higher tissue exposure at lower doses, generating interest among KOLs .
  • UC patient study design: Specifics to follow after MAD data and KOL feedback; study expected to initiate in 2H 2024 .
  • BioJet partnering scope: Seeking partners ready to take molecules into clinic; aiming to preserve optionality rather than broad exclusivity; decision timing “fairly soon” .
  • Pipeline considerations: Adalimumab biosimilar program’s go/no-go to be informed by BT-600 outcomes; potential for shorter development program .
  • Capital structure outlook: Further simplification anticipated; catalysts expected to guide next steps .

Estimates Context

  • S&P Global consensus estimates for Q1 2024 EPS and revenue were unavailable for BIOR in our system, preventing beat/miss comparisons for the quarter [GetEstimates error: BIOR mapping not available].
  • Given the pre-revenue profile and limited analyst coverage, future estimates could become more relevant post BT-600 readouts and upon BioJet partnering updates .

Key Takeaways for Investors

  • Near-term catalysts (late-Q2 topline BT-600 data; DDW device function presentation) could drive re-rating if colon-targeted efficacy and safety profiles are confirmed in multi-dose and tissue analyses .
  • The NaviCap approach (higher tissue concentration with lower systemic exposure) positions BT-600 for potential improved induction efficacy and reduced toxicity, with combination therapy optionality over time .
  • BioJet’s validated bioavailability and BD interest set up a 2024 partnership narrative; partner selection that preserves BIOR’s optionality could be a key value driver .
  • Capital structure has materially improved via note exchanges and fresh capital; continued optimization could reduce financing overhang ahead of clinical milestones .
  • Lack of available consensus estimates makes relative-performance trading more event-driven; timing the late-Q2 readout and mid-year partnering updates is likely central to positioning .
  • Watch for UC patient study initiation in 2H 2024 and clarity on trial design; outcomes could expand BT-600’s potential line-of-therapy positioning .
  • Risk factors remain: execution risk in clinical readouts, partner negotiations, and ongoing balance sheet complexity (warrant/derivative liabilities), albeit with active management mitigation .

Appendix: Source Citations

  • Q1 2024 8-K press release, financials, and milestones: .
  • Q1 2024 earnings call transcript: clinical, BioJet, capital markets commentary and Q&A: –.
  • Prior quarter references for trend analysis (Q4 2023 and Q3 2023): – .